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July 01, 2014

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took part in a BIO session that provided some of the Office's initial observations regarding written comments submitted to date on the Myriad-Mayo guidance memorandum that was issued on March 4, 2014. Mr. Hirshfeld began the presentation by noting that the Office was eager to receive public feedback on the Guidance, including examples of claims that might be presented in supplemental guidance the Office expected to issue after the July 31 deadline for submitting comments.

Before turning to several additional exemplary claims for which the Office was seeking public input, Mr. Hirshfeld addressed several issues involving the Guidance that had been raised in comments already received by the Office. First, in response to comments that suggested the Guidance be limited to Myriad, he noted that while the Office had considered limiting the Guidance to Myriad, it instead responded to requests from examiners for more comprehensive guidance. Despite the negative response to the Guidance from the patent community, Mr. Hirshfeld still felt that the Office's approach was the right one. He also explained that the Office's intent in the Guidance was to inform examiners that terms such as "isolated" did not have a per se meaning. In other words, the recitation of, for example, an "isolated nucleic acid molecule" conveyed neither per se patent eligibility nor per se patent ineligibility on the "nucleic acid molecule."

In response to comments suggesting that the Office had created a new legal standard with its use of a "significantly different" requirement in the Guidance, Mr. Hirshfeld noted that this was not the Office's intent. Instead, he explained that the "significantly different" standard in the Guidance was only a teaching tool for examiners.

Finally, with respect to comments that were critical of the Guidance for overlooking the importance of functional differences in establishing patent eligibility, Mr. Hirshfeld pointed out that this was an area where there was a lot of common ground between the Office and critics of the Guidance. He noted that the Office had received significant feedback on this issue and that the Office agreed that functional differences need to be taken into account when assessing patent eligibility, stating that "there is room between Funk Brothers and Chakrabarty." However, Mr. Hirshfeld admitted that the Office has been struggling with claims reciting a single product (as opposed to combinations) in which the product differs functionally, but not structurally, from a naturally occurring product. As for combination claims, Mr. Hirshfeld noted that significant public feedback had been received and that much of it disagreed with the Office's handling of such claims. He acknowledged that the Office "could be doing more on our end." Finally, with respect to derivatives of natural products, Mr. Hirshfeld indicated that it was not the Office's intent to render all derivatives patent ineligible, and he suggested that "a lot of clarity was needed on this."

Mr. Hirshfeld closed his portion of the presentation by pointing out that the Office had received a lot of feedback criticizing Funk Brothers and Mayo as not being good law, and asking the Office to not apply these cases. In response, he noted that Office did not intend to ignore any cases, and suggested that "we need to draw the right lines" instead.

Ms. Cohan followed Mr. Hirshfeld's presentation by providing seven exemplary claims "for discussion purposes." The exemplary claims that were presented are as follows:

During her presentation, Ms. Cohan noted that the Office was trying to resolve how applicants could establish patent eligibility by showing differences in function or use (as opposed to the Guidance's focus on structural differences). In particular, she posed the question of whether a difference in function or use would by itself constitute a marked difference, and invited public comment on the issue.

Following Ms. Cohan's presentation, Mr. Hirshfeld opened the floor for questions. In response to a question about whether a course correction was needed, Mr. Hirshfeld noted that the Office would be issuing iterations to the guidance, and whether such iterations could be considered a course correction would be in the eye of the beholder. He reiterated, however, that clarity was needed with respect to derivatives of natural products, functional language, and combination claims. Mr. Hirshfeld also stated that "no one should leave here today thinking we are not making changes," declaring that "we will be making changes."

Another attendee asked the Office to consider taking a different approach with the Guidance. Noting that the patent community is dealing with a negative Supreme Court, she suggested that the Office "push back wherever you can," adding that if the Office "buy[s] into what the Supreme Court says, then you're going to damage the biotech industry." Those in attendance responded with a round of applause.

In a post-Convention discussion with Mr. Hirshfeld and Ms. Cohan, Patent Docs was informed that the claims presented at the BIO Convention have now been posted on the Guidance webpage as part of seven-slide PowerPoint presentation. Mr. Hirshfeld explained that the Office posted the claims on the Guidance webpage in order to obtain feedback from the public. Slide 3 of the presentation provides the following factual assumptions for the seven claims that were presented at BIO:

• Antibiotic L is a naturally occurring protein produced by a particular bacterial species. It exhibits antibiotic activity in nature (e.g., it kills other bacterial species in its natural environment).

• Antibodies to Antibiotic L are naturally occurring in wild coyotes, but not in humans or mice.

Mr. Hirshfeld noted that the Office's inclination was that the seven claims presented at the BIO Convention were examples of things that, in the right context, would be patent eligible. He indicated that the Office was now tasked with formulating supplemental guidance that provided the right context for these claims (provided that these claims make it into the supplemental guidance) as well as any other claims that might make it into the supplemental guidance.

Comments

"First, in response to comments that suggested the Guidance be limited toMyriad, he noted that while the Office had considered limiting the Guidance to Myriad, it instead responded to requests from examiners for more comprehensive guidance."

Wrong. We requested CLEARER guidance, not this mess. And it was OPLA's interpretation of Myriad and Mayo that originally created the confusion that led to the need for clearer guidance (which this is not). Viscious OPLA cycle/tornado...

Don, I think you should have mentioned that the attendee who said that the PTO needs to push back was Nancy Linck, former solicitor at the PTO and herself a veteran of the PTO guideline-making process.